Common use of Other Regulatory Interactions before Option Exercise Clause in Contracts

Other Regulatory Interactions before Option Exercise. Any interactions Akcea has or plans to have with a Regulatory Authority for a Product before Option Exercise (other than the End of Phase 2b Meeting under Section 1.2.5), including any meetings, correspondence and submissions, shall be the sole responsibility of Akcea. Subject to Section 2.1.3(a), Akcea shall present to the CSC for the CSC’s review and comment, Akcea’s material planned * ***Confidential Treatment Requested interactions and material submissions to Regulatory Authorities in Major Markets in accordance with the principles set forth in ARTICLE 2.

Other Regulatory Interactions before Option Exercise. Any interactions Akcea has or plans to have with a Regulatory Authority for a Product before Option Exercise (other than the End of Phase 2b Meeting under Section 1.2.5), including any meetings, correspondence and submissions, shall be the sole responsibility of Akcea. Subject to Section 2.1.3(a), Akcea shall present to the CSC for the CSC’s review and comment, Akcea’s material planned * ***Confidential Treatment Requested interactions and material submissions to Regulatory Authorities in Major Markets in accordance with the principles set forth in ARTICLE 2.

Other Regulatory Interactions before Option Exercise. Any interactions Akcea has or plans to have with a Regulatory Authority for a Product before Option Exercise (other than the End of Phase 2b Meeting under Section 1.2.5), including any meetings, correspondence and submissions, shall be the sole responsibility of AkceaXxxxx. Subject to Section 2.1.3(a), Akcea shall present to the CSC for the CSC’s review and comment, AkceaXxxxx’s material planned * ***Confidential Treatment Requested 6 interactions and material submissions to Regulatory Authorities in Major Markets in accordance with the principles set forth in ARTICLE 2.